Gary P. Siskin

Outpatient Uterine Artery Embolization for Symptomatic Uterine Fibroids: Experience in 49 Patients

PURPOSE To assess the feasibility of performing uterine artery embolization as an outpatient treatment for symptomatic uterine fibroids. MATERIALS AND METHODS Forty-nine consecutive patients (mean age, 44.5 years; range, 28-54 years) underwent uterine artery embolization during a 12-month period. Embolization was performed with 350-500 microm polyvinyl alcohol particles (44 of 49) or Gelfoam pledgets (five of 49). At discharge, patients were given instructions regarding the constitutional symptoms to expect after embolization. A specific medication regimen consisting of prochlorperazine, ketorolac, meperidine, and hydrocodone was prescribed for relief of these symptoms. All patients were telephoned within 24 hours of discharge. During long-term follow-up, a questionnaire was administered to all patients to evaluate the periprocedural experience. Three-month clinical follow-up was available in 26 patients and 6-month imaging follow-up was available in 16 patients. RESULTS Fourteen patients presented with menorrhagia, six had bulk-related symptoms (abdominal distension, stress incontinence, pelvic pain), and 29 had both. Technical success for bilateral embolization was 98%. Forty-seven of 49 patients were discharged to home 6-8 hours after the procedure; two patients required overnight observation in an ambulatory unit (one because of postprocedure hypertension and one because of a late procedure completion time). At the first follow-up phone call, reported symptoms included pelvic pain/cramping in 83.7% (41 of 49), fatigue in 75.5% (37 of 49), nausea/vomiting in 46.9% (23 of 49), and a nonpurulent vaginal discharge in 18.4% (nine of 49). These symptoms were satisfactorily controlled with discharge medications in 48 of 49 patients. No patients returned to the hospital or visited an emergency room during the first 48 hours after discharge. Forty-six of 49 patients were satisfied with the decision for home discharge. The average uterine volume reduction in 16 patients with 6-month imaging follow-up was 47.5%; 88.5%, of patients (23 of 26) with 3-month clinical follow-up reported improvement or elimination of symptoms. CONCLUSION With defined telephone follow-up, staff availability, and a protocol designed to alleviate the postprocedure constitutional symptoms, uterine artery embolization is both safe and effective when performed as an outpatient procedure.

A Prospective Multicenter Comparative Study between Myomectomy and Uterine Artery Embolization with Polyvinyl Alcohol Microspheres: Long-term Clinical Outcomes in Patients with Symptomatic Uterine Fibroids

PURPOSE To prospectively evaluate the safety and effectiveness of polyvinyl alcohol (PVA) microspheres in patients undergoing uterine artery embolization (UAE) to treat uterine fibroid tumors and to compare the long-term changes in health-related quality of life (QOL) after UAE with the changes seen after myomectomy. MATERIALS AND METHODS One hundred forty-six patients with uterine myomas were enrolled into this multicenter study, with 77 patients undergoing UAE with PVA and 69 patients undergoing myomectomy. Six-month follow-up was completed for the myomectomy, whereas 2-year follow-up was completed for the UAE group. Outcomes were assessed with the Uterine Fibroid QOL Questionnaire and based on adverse event incidence, time to return to normal activity, and changes in tumor symptom scores, QOL scores, and menorrhagia bleeding scores. For the UAE cohort, changes in total uterine volume and dominant tumor size on magnetic resonance (MR) imaging were assessed. RESULTS In the UAE cohort, 88.3% of patients experienced a reduction of tumor-related symptoms (increase >or=5 points from baseline measurement) at 6 months, with 75.4% of patients in the myomectomy group experiencing similar improvement. Median QOL questionnaire scores at 6 months were found to be significantly higher in patients treated with UAE (P = .041), with sustained improvement seen at 12 and 24 months. Both procedures resulted in significant reductions in 6-month menorrhagia bleeding scores, with sustained improvement in the UAE cohort at 12 and 24 months. MR imaging at 6 months revealed significant uterine and tumor volume reductions after UAE (P < .05). At least one adverse event occurred in 42% of patients in the myomectomy group, compared with 26% in the UAE group (P < .05). CONCLUSIONS UAE performed with PVA microspheres was associated with greater sustained improvements in symptom severity and health-related QOL and with fewer complications compared with myomectomy. Six-month MR imaging data demonstrated significant reductions in uterine and tumor volumes, although the degree of tissue infarction after UAE was not assessed with contrast medium-enhanced MR imaging.

Radioembolisation for liver metastases: Results from a prospective 151 patient multi-institutional phase II study

PURPOSE To investigate the safety, response rate, progression-free and overall survival of patients with liver metastases treated with (90)Y (glass) radioembolisation in a prospective, multicenter phase II study. METHODS 151 patients with liver metastases (colorectal n=61, neuroendocrine n=43 and other tumour types n=47) refractory to standard of care therapies were enrolled in this prospective, multicenter, phase II study under an investigational device exemption. Clinical/laboratory/imaging follow-up were obtained at 30 days followed by 3-month intervals for 1 year and every 6 months thereafter. The primary end-point was progression-free survival (PFS); secondary end-points included safety, hepatic progression-free survival (HPFS), response rate and overall survival. RESULTS Median age was 66 (range 25-88). Grade 3/4 adverse events included pain (12.8%), elevated alkaline phospatase (8.1%), hyperbilirubinemia (5.3%), lymphopaenia (4.1%), ascites (3.4%) and vomiting (3.4%). Treatment parameters including dose delivery were reproducible among centers. Disease control rates were 59%, 93% and 63% for colorectal, neuroendocrine and other primaries, respectively. Median PFS was 2.9 and 2.8 months for colorectal and other primaries, respectively. PFS was not achieved in the neuroendocrine group. Median survival from (90)Y treatment was 8.8 months for colorectal and 10.4 months for other primaries. Median survival for neuroendocrine patients has not been reached. CONCLUSION Patients with liver metastases can be safely treated with (90)Y microspheres. This study is the first to demonstrate technical and dose reproducibility of (90)Y glass microspheres between centers in a prospective setting. Based on these promising data, three international, multicenter, randomised phase III studies in colorectal and hepatocellular carcinoma have been initiated.

Safety of Endovascular Treatment of Chronic Cerebrospinal Venous Insufficiency: A Report of 240 Patients with Multiple Sclerosis

PURPOSE To evaluate the safety of outpatient endovascular treatment in patients with multiple sclerosis (MS) and chronic cerebrospinal venous insufficiency (CCSVI). MATERIALS AND METHODS A retrospective analysis was performed to assess complications occurring within 30 days of endovascular treatment of CCSVI. The study population comprised 240 patients; 257 procedures were performed over 8 months. The indication for treatment in all patients was symptomatic MS. Of the procedures, 49.0% (126 of 257) were performed in a hospital, and 51.0% (131 of 257) were performed in the office. Primary procedures accounted for 93.0% (239 of 257) of procedures, and repeat interventions accounted for 7% (18 of 257). For patients treated primarily, 87% (208 of 239) had angioplasty, and 11% (26 of 239) had stent placement; 5 patients were not treated. Of patients with restenosis, 50% (9 of 18) had angioplasty, and 50% (9 of 18) had stent placement. RESULTS After the procedure, all but three patients were discharged within 3 hours. Headache after the procedure was reported in 8.2% (21 of 257) of patients; headache persisted > 30 days in 1 patient. Neck pain was reported in 15.6% (40 of 257); 52.5% (21 of 40) of these patients underwent stent placement. Three patients experienced venous thrombosis requiring retreatment within 30 days. Sustained intraprocedural arrhythmias were observed in three patients, and two required hospital admission. One of these patients, who was being retreated for stent thrombosis, was hospitalized because of a stress-induced cardiomyopathy. CONCLUSIONS Endovascular treatment of CCSVI is a safe procedure; there is a 1.6% risk of major complications. Cardiac monitoring is essential to detect intraprocedural arrhythmias. Ultrasonography after the procedure is recommended to confirm venous patency and to identify patients experiencing acute venous thrombosis.

Quality Improvement Guidelines for Uterine Artery Embolization for Symptomatic Leiomyomata

Uterine artery embolization (UAE) is assuming an important role in the treatment of women with symptomatic uterine leiomyomata worldwide. The following guidelines, which have been jointly published with the Society of Interventional Radiology in the Journal of Vascular and Interventional Radiology, are intended to ensure the safe practice of UAE by identifying the elements of appropriate patient selection, anticipated outcomes, and recognition of possible complications and their timely address.

Management of splenic trauma: a single institution’s 8-year experience

BACKGROUND Management of splenic trauma has evolved, with current practice favoring selective angiographic embolization and non-operative treatment over immediate splenectomy. Defining the optimal selection criteria for the appropriate management strategy remains an important question. METHODS This retrospective registry review was conducted at a Level I trauma center. The patient population consisted of 20,561 patients in the State Trauma Registry from April 2004 to May 2012. Splenectomy, angiography, splenic embolization, nonoperative, and noninterventional (NI) observation were the management strategies under study. Morbidity and mortality were the outcome measures. Morbidity and mortality by management strategy. RESULTS During the 8-year study period, 926 (4.5%) patients sustained splenic injury. Observational management increased over time despite the similar distribution of splenic injury grade over the study period: grade I/II (50%), grade III (24.2%), and grade IV/V (25.8%). Mortality rates associated with each management strategy were the following: immediate splenectomy (IS; 25%), splenic embolization (SE; 3.9%), and angiography only or observation, that is, NI (6.5%) management. Injury severity score (ISS) was highest in IS (36.1 ± 1.3) compared with SE (29.1 ± 1.0, P = .001) and NI (21.6, P < .001). Splenectomy was required in 5 of the 129 (3.9%) patients managed with SE and 9 of the 677 (1.3%) patients managed by NI. Mortality was significantly lower among those managed by SE (odds ratio .12, 95% confidence interval: .05 to .32) or NI (odds ratio .21, 95% confidence interval: .12 to .35). This survival benefit was explained by the association of IS with systolic blood pressure <90, high ISS, low GCS at presentation, ISS, development of shock, need for transfusion, and multiorgan failure. CONCLUSIONS In this large 8-year single institution study, we observed an increase in nonoperative management by an increased application of angiography and embolization. An aggressive utilization of SE in patients with appropriate indications will result in low failure rates and improved mortality.

Results of Iliac Artery Stent Placement in Patients Younger than 50 Years of Age

PURPOSE To determine long-term outcome in patients 50 years of age or younger treated with iliac artery stent placement. MATERIALS AND METHODS The records of 412 patients who underwent iliac artery stent placement during a 62-month study period were reviewed retrospectively. Forty-two patients younger than age 50 (mean age = 45 y) at the time of stent placement were included in the study population. Presenting symptoms included claudication (47%), rest pain (17%), ulceration/tissue loss (31%), and blue toe syndrome (5%). Anatomic, hemodynamic, and clinical success rates of the stent placement procedure were assessed. Stent patency rates were calculated by life-table methods. RESULTS Fifty-nine iliac lesions were treated with stents; 62% of patients underwent treatment of a single lesion whereas 38% had multiple lesions treated. Thirty-one percent were treated after a failed angioplasty procedure and 69% were treated with stent placement primarily. After stent placement, 34 patients (82%) experienced symptomatic relief, although eight of these patients (19%) underwent a planned ipsilateral infrainguinal bypass procedure during the same hospitalization. During follow-up, five patients (12%) required a bypass procedure as a result of stent failure and two patients (5%) required below-knee amputation. Seven patients (17%) required endovascular stent revision, with none requiring additional surgery. At 1, 2, and 3 years, the primary patency rates were 86%, 72%, and 65%, and the secondary patency rates were 90%, 88%, and 88%, respectively. CONCLUSIONS Iliac stent placement successfully addresses the presenting symptoms of young patients with peripheral vascular disease and results in patency rates that are similar to those reported in a more general population. With appropriate postprocedural surveillance, restenosis can be addressed in many patients with use of endovascular techniques, limiting the need for surgical revision.

Review of Venous Anatomy for Venographic Interpretation in Chronic Cerebrospinal Venous Insufficiency

Chronic cerebrospinal venous insufficiency (CCSVI) represents a recently described condition that may potentially contribute to the symptoms experienced by patients with multiple sclerosis. The evaluation of a prospective patient for CCSVI often involves an invasive evaluation with venography of the internal jugular and azygos veins. The purpose of this article is to review the normal anatomy of the internal jugular, vertebral, and azygos veins, as an understanding of these veins is necessary for appropriate interpretation of the venograms obtained to evaluate patients for CCSVI.

Subcutaneous Implantable Cardioverter Defibrillator for Dialysis Patients: A Strategy to Reduce Central Vein Stenoses and Infections

Central venous stenosis is a common complication of the transvenous leads associated with an implantable cardioverter defibrillator (ICD). Although epicardial leads have been reported to bypass this complication, their placement is much more invasive than the subcutaneous ICDs (SICDs) and requires the services of a cardiothoracic surgeon. Recent data have demonstrated successful defibrillation using an SICD. In this report, we present 4 long-term hemodialysis patients treated successfully with an SICD. 3 patients received the device for primary prevention of sudden cardiac death (cardiomyopathy with low ejection fraction). The patient in the fourth case had a prolonged QT interval and received the device for secondary prevention. 3 patients had an arteriovenous fistula, whereas 1 patient was dialyzing with a tunneled dialysis catheter. Insertion of an SICD is a minimally invasive procedure. By virtue of leaving the venous system untouched, this approach might offer the advantage of reduced risk of central venous stenosis and infection over an endocardial ICD with transvenous leads. SICD is not experimental; it has been approved by the US Food and Drug Administration and is currently being used in the United States and Europe.

Internet-Based Social Networking and Its Role in the Evolution of Chronic Cerebrospinal Venous Insufficiency

The Internet is being seen as a growing resource for health-related information for a large number of patients. It is undeniable that its widespread presence has led to the growth of awareness that chronic cerebrospinal venous insufficiency (CCSVI) as an entity that may contribute to the symptoms experienced by patients with multiple sclerosis (MS). Social networking and file-sharing Web sites have brought patients with MS together from all over the world and have facilitated the distribution of personal experiences and information derived from medical research as it relates to CCSVI. As a result, there has been an accelerated growth in the number of patients seeking treatment for this syndrome in light of the possibility that it may improve their present condition. This article will review this phenomenon, the Internet-based resources available to MS patients seeking information about CCSVI, and the responsibilities of physicians as they participate in these online discussions.